DOXEPIN CREAM 5% (Prudoxin, Zonalon)
Pre - PA Allowance Age 18 years of age or older Quantity 60 grams every 90 days ______
Prior-Approval Requirements
Age 18 years of age or older
Diagnosis
Patient must have the following:
Moderate pruritus, due to atopic dermatitis (eczema) or lichen simplex chronicus
AND the following: 1. Inadequate response, intolerance or contraindication to ONE medication in EACH of the following categories: a. Topical antihistamine (see Appendix I) b. High potency topical corticosteroid (see Appendix II)
2. Physician agrees to taper patient’s dose to the FDA recommended dose, and after tapered will only use for short-term pruritus relief (up to 8 days) a. Patients using over 60 grams of topical doxepin in 90 days be required to taper to 60 grams topical doxepin within 90 days
Prior - Approval Limits Quantity 180 grams for 90 days Duration 3 months ______
Prior – Approval Renewal Requirements None
(see appendix below)
Doxepin 5% cream FEP Clinical Rationale DOXEPIN CREAM 5% (Prudoxin, Zonalon)
APPENDIX I Drug Dosage Form Diphenhydramine Cream Phenyltoloxamine Lotion/ Cream Tripelennamine Cream Phendiamine Cream
APPENDIX II Relative Potency of Selected Topical Corticosteroid Drug ProductsDosage Form Strength I. Very high potency Augmented betamethasone Ointment, Gel 0.05% dipropionate Clobetasol propionate Cream, Ointment 0.05% Diflorasone diacetate Ointment 0.05% Halobetasol propionate Cream, Ointment 0.05% II. High potency Amcinonide Cream, Lotion, 0.1% Augmented betamethasone Cream,Ointment Lotion 0.05% dipropionate Betamethasone Cream, Ointment 0.05% Betamethasonedipropionate valerate Ointment 0.1% Desoximetasone Cream, Ointment 0.25% Gel 0.05% Diflorasone diacetate Cream, Ointment 0.05%
(emollient base) Fluocinonide Cream, Ointment, Gel 0.05% Halcinonide Cream, Ointment 0.1% Triamcinolone acetonide Cream, Ointment 0.5% III. Medium potency Betamethasone Lotion 0.05% Betamethasonedipropionate valerate Cream 0.1% Clocortolone pivalate Cream 0.1% Desoximetasone Cream 0.05% Fluocinolone acetonide Cream, Ointment 0.025% Flurandrenolide Cream, Ointment, 0.05% 2 TapeLotion 4 mcg/cm Fluticasone propionate Cream 0.05% Ointment 0.005% Hydrocortisone butyrate Ointment, Solution 0.1% Hydrocortisone valerate Cream, Ointment 0.2%
Doxepin 5% cream FEP Clinical Rationale DOXEPIN CREAM 5% (Prudoxin, Zonalon)
Mometasone furoate Cream, Ointment, 0.1% 2 Prednicarbate Cream,Lotion Ointment 0.1%
III. Triamcinolone acetonide Cream, Ointment, 0.025%
Lotion
Cream, Ointment, 0.1% Lotion IV. Low potency Alclometasone dipropionate Cream, Ointment 0.05% Desonide Cream 0.05% Fluocinolone acetonide Cream, Solution 0.01% Hydrocortisone Lotion 0.25% Cream, Ointment, 0.5% Lotion,
Cream,Aerosol Ointment, 1% Lotion,
Cream,Solution Ointment, 2.5% Hydrocortisone acetate Cream,Lotion Ointment 0.5% Cream, Ointment 1%
Doxepin 5% cream FEP Clinical Rationale